CLINICAL TRIALS PROFILE FOR VOLTAREN

All Clinical Trials for Voltaren

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00171691 ↗	Safety of Diclofenac Sodium Gel in Knee Osteoarthritis	Completed	Novartis	Phase 3	2004-10-01	This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.
NCT00276419 ↗	Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin	Terminated	Mayo Clinic	Phase 2/Phase 3	2005-06-01	The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.
NCT00310908 ↗	Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic	Completed	Grumental	Phase 4	2006-09-01	The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
NCT00310908 ↗	Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic	Completed	Hadassah Medical Organization	Phase 4	2006-09-01	The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute renal colic.
NCT00523120 ↗	Topical Voltaren in Otitis Externa	Terminated	Sieff Medical Center	Phase 2	2008-09-01	Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.
NCT00715091 ↗	Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) on RAdiographic Damage in Ankylosing Spondylitis	Completed	Charite University, Berlin, Germany	Phase 4	2008-09-01	This is a randomised, controlled, multi-centre clinical trial on AS patients. Experimental intervention: continuous (daily) treatment with diclofenac cholestyramine 150 mg (Voltaren Resinate), divided into 75mg Voltaren twice dailyControl intervention: treatment on-demand (as needed) with diclofenac-cholestyramine 75 to 150 mg (Voltaren Resinate). The treatment strategy of the control intervention (on-demand) reflects current clinical practice in AS. Duration of intervention per patient: 2 years Follow-up per patient: safety assessment 3 months after termination of the trial.
NCT00766402 ↗	An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)	Terminated	Johnson & Johnson Taiwan Ltd	Phase 4	2008-10-01	The purpose of the study is to investigate the clinical benefit of tramadol/acetaminophen versus non-steroidal anti-inflammatory drugs (NSAID) (diclofenac 50 milligram [mg]) in the treatment of pain in participants with ankylosing spondylitis (inflammation of the spine causing pain and stiffness) receiving stable treatment of disease modifying anti-rheumatic drugs (DMARDs).

Clinical Trial Conditions for Voltaren

Condition Name

Condition Name for Voltaren
Intervention	Trials
Pain	10
Knee Osteoarthritis	4
Osteoarthritis	3
Osteoarthritis, Knee	2

Condition MeSH

Condition MeSH for Voltaren
Intervention	Trials
Osteoarthritis	10
Osteoarthritis, Knee	9
Renal Colic	3
Temporomandibular Joint Dysfunction Syndrome	3

Clinical Trial Locations for Voltaren

Trials by Country

Trials by Country for Voltaren
Location	Trials
United States	47
India	22
China	8
Egypt	8
Germany	6

Trials by US State

Trials by US State for Voltaren
Location	Trials
Florida	4
California	3
Pennsylvania	3
Louisiana	2
Georgia	2

Clinical Trial Progress for Voltaren

Clinical Trial Phase

Clinical Trial Phase for Voltaren
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Voltaren
Clinical Trial Phase	Trials
Completed	30
Recruiting	9
Unknown status	8

Clinical Trial Sponsors for Voltaren

Sponsor Name

Sponsor Name for Voltaren
Sponsor	Trials
Cairo University	5
ZetrOZ, Inc.	2
Assiut University	2

Sponsor Type

Sponsor Type for Voltaren
Sponsor	Trials
Other	50
Industry	34
U.S. Fed	1

Voltaren: Clinical Trials, Market Analysis, and Projections

Last updated: January 7, 2025

Introduction

Voltaren, a non-steroidal anti-inflammatory drug (NSAID) formulated as a topical gel or emulgel, has been a significant player in the management of pain associated with osteoarthritis and other musculoskeletal disorders. Here, we delve into the clinical trials that have validated its efficacy, analyze the current market trends, and project its future growth.

Clinical Trials and Efficacy

Approval and Clinical Studies

Voltaren Gel (diclofenac sodium topical gel) received US regulatory approval in 2007 as the first topical prescription treatment for pain associated with osteoarthritis in joints such as the knees and hands[1].

• Pain Reduction: Clinical trials demonstrated that Voltaren Gel significantly reduced pain in patients with osteoarthritis. In a 12-week study, it showed a 51% reduction in pain for patients with osteoarthritis of the knee, and a 46% reduction in pain for those with osteoarthritis of the hand[1].
• Safety Profile: The trials highlighted that Voltaren Gel has a favorable safety profile, with systemic absorption 94% less than comparable oral diclofenac treatments, minimizing the risk of side effects[1].

Additional Studies

Other formulations, such as Voltaren Emulgel, have also been studied for their efficacy in treating pain associated with recent muscle or joint injuries. These studies, conducted in Canada, showed that Voltaren Emulgel significantly reduced pain in patients compared to placebo[4].

Market Analysis

Global Market Size

As of 2024, the global Voltaren market size is estimated to be USD 5521.5 million. This market is projected to grow at a compound annual growth rate (CAGR) of 4.50% from 2024 to 2031, reaching USD 7513.99 million by 2031[2].

Regional Market Share

• North America: This region dominates the Voltaren market, holding more than 40% of the global revenue with a market size of USD 2208.60 million in 2024. It is expected to grow at a CAGR of 2.7% from 2024 to 2031[2].
• Europe: Europe holds around 30% of the global revenue, with a market size of USD 1656.45 million in 2024, and is expected to grow at a CAGR of 3.0% from 2024 to 2031[2].
• Asia Pacific: This region accounts for around 23% of the global revenue, with a market size of USD 1269.95 million in 2024, and is projected to grow at a CAGR of 6.5% from 2024 to 2031[2].

Market Drivers

The growth of the Voltaren market is driven by several key factors:

• Increasing Prevalence of Musculoskeletal Disorders: Conditions such as arthritis, osteoarthritis, and chronic back pain are becoming more prevalent, especially among the aging population[2][3].
• Preference for Topical Treatments: Patients are increasingly opting for topical treatments like Voltaren due to their targeted pain relief and fewer side effects compared to oral medications[2].
• Improved Healthcare Access and Awareness: Better healthcare infrastructure and increased awareness of pain management options are driving demand for effective over-the-counter solutions like Voltaren[2].

Market Projections

Growth Outlook

The global Voltaren market is expected to continue its growth trajectory, driven by the increasing demand for effective pain relief solutions. Here are some key projections:

• Global Growth: The market is projected to reach USD 7513.99 million by 2031, growing at a CAGR of 4.50% from 2024 to 2031[2].
• Regional Growth: North America, Europe, and Asia Pacific are expected to see significant growth, with Asia Pacific showing the highest CAGR of 6.5% during the forecast period[2].

Challenges and Opportunities

While the market is poised for growth, it also faces some challenges:

• Side Effects: Potential side effects associated with diclofenac, such as cardiovascular and gastrointestinal issues, could restrain market expansion. However, innovations in formulation and delivery methods aimed at minimizing these side effects are likely to support the market’s growth[3].
• Regulatory Changes: The recent approval of Voltaren Arthritis Pain for over-the-counter use in the US is expected to expand its market reach and accessibility[5].

Key Takeaways

• Clinical Efficacy: Voltaren has been clinically proven to significantly reduce pain in patients with osteoarthritis and other musculoskeletal disorders.
• Market Size and Growth: The global Voltaren market is substantial and growing, with a projected size of USD 7513.99 million by 2031.
• Regional Dominance: North America currently dominates the market, but Asia Pacific is expected to show the highest growth rate.
• Market Drivers: Increasing prevalence of musculoskeletal disorders, preference for topical treatments, and improved healthcare access are key drivers.
• Challenges and Opportunities: While side effects are a concern, innovations and regulatory changes are expected to support market growth.

FAQs

What is Voltaren and how does it work?

Voltaren is a non-steroidal anti-inflammatory drug (NSAID) available as a topical gel or emulgel. It works by reducing inflammation and pain directly at the site of application, with significantly less systemic absorption compared to oral NSAIDs.

What conditions is Voltaren approved for?

Voltaren is approved for the treatment of pain associated with osteoarthritis in joints such as the knees and hands, as well as for relief of pain from recent muscle or joint injuries.

What are the key benefits of using Voltaren?

The key benefits include targeted pain relief with fewer side effects compared to oral medications, a favorable safety profile, and the convenience of at-home pain management.

How large is the global Voltaren market?

As of 2024, the global Voltaren market size is estimated to be USD 5521.5 million.

What is the projected growth rate of the Voltaren market?

The global Voltaren market is projected to grow at a CAGR of 4.50% from 2024 to 2031.

Sources

1. Fierce Biotech: "Voltaren Gel Receives US Regulatory Approval"
2. Cognitive Market Research: "Global Voltaren Market Report 2025"
3. News Market: "Diclofenac Market Growth Accelerates Amid Increased Demand"
4. Health Canada: "Summary Basis of Decision for Voltaren™ Emulgel™"
5. GSK: "FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States"